Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
Queensland Health
Boehringer Ingelheim
Healthtrust
Chubb

Generated: September 18, 2019

DrugPatentWatch Database Preview

Cysteamine bitartrate - Generic Drug Details

  Try a free trial


See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for cysteamine bitartrate and what is the scope of cysteamine bitartrate freedom to operate?

Cysteamine bitartrate is the generic ingredient in two branded drugs marketed by Horizon Pharma Usa and Mylan, and is included in two NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cysteamine bitartrate has forty-two patent family members in twenty-eight countries.

There are six drug master file entries for cysteamine bitartrate. Two suppliers are listed for this compound.

Summary for cysteamine bitartrate
Pharmacology for cysteamine bitartrate
Synonyms for cysteamine bitartrate
(+/-)-Tartaric Acid
2-aminoethanethiol 2,3-dihydroxysuccinate
27761-19-9
AKOS024332936
AKOS032954217
BC245627
BCP15048
beta-Mercaptoethylamine bitartrate
beta-Mercaptoethylamine hydrogen tartrate
CHEBI:50386
CHEMBL2062263
CTK4G0224
Cysteamine bitartrate (JAN)
D10468
EINECS 248-641-7
Ethanethiol, 2-amino-, tartrate (1:1) (salt)
FT-0696891
MCULE-1129308393
Mercaptamine bitartrate
Procysbi
Procysbi (TN)
QO84GZ3TST
RP103
SCHEMBL49513
UNII-QO84GZ3TST

US Patents and Regulatory Information for cysteamine bitartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes   Try a Free Trial   Try a Free Trial   Try a Free Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-001 Apr 30, 2013 RX Yes No   Try a Free Trial   Try a Free Trial Y   Try a Free Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes   Try a Free Trial   Try a Free Trial Y Y   Try a Free Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-001 Apr 30, 2013 RX Yes No   Try a Free Trial   Try a Free Trial Y   Try a Free Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-001 Apr 30, 2013 RX Yes No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Mylan CYSTAGON cysteamine bitartrate CAPSULE;ORAL 020392-002 Aug 15, 1994 RX Yes Yes   Try a Free Trial   Try a Free Trial   Try a Free Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes   Try a Free Trial   Try a Free Trial   Try a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Subscribe to access the full database, or try a Free Trial

International Patents for cysteamine bitartrate

Supplementary Protection Certificates for cysteamine bitartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1919458 122014000023 Germany   Try a Free Trial PRODUCT NAME: CYSTEAMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/861 20130906
1919458 2014C/018 Belgium   Try a Free Trial PRODUCT NAME: CYSTEAMINE; AUTHORISATION NUMBER AND DATE: EU/1/13/861 20130910
1919458 C 2014 012 Romania   Try a Free Trial PRODUCT NAME: CISTEAMINABITARTRAT; NATIONAL AUTHORISATION NUMBER: EU/1/13/861; DATE OF NATIONAL AUTHORISATION: 20130906; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/861; DATE OF FIRST AUTHORISATION IN EEA: 20130906
1919458 C300649 Netherlands   Try a Free Trial PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130906
1919458 194 50001-2014 Slovakia   Try a Free Trial PRODUCT NAME: MERKAPTAMIN; FIRST REGISTRATION: EU/1/13/861, 20130906
1919458 300649 Netherlands   Try a Free Trial PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
1919458 19/2014 Austria   Try a Free Trial PRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Subscribe to access the full database, or try a Free Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo
Chubb
Teva
Cipla
Deloitte

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.